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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06187233
Other study ID # colonoscopybinaural
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2023
Est. completion date November 30, 2023

Study information

Verified date December 2023
Source Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study was to investigate the effect of binaural beats on anxiety, pain and tolerance during colonoscopy without sedation


Description:

It is a prospective randomized, controlled, single-blind procedural study included 92 Turkish patients aged 18-70 years old scheduled for colonoscopy regardless of sex or underlying disease. The patients were randomly divided into two groups: the binaural beat music group(n=46) and the control group(n=46). The binaural music group listened to music through headphones during colonoscopy, while the control group had headphones without music. Anxiety levels (VAS-Anxiety scale) were measured both before and after the procedure, and pain levels (VAS-pain) were measured following the procedure. Hemodynamic changes before and after endoscopy , procedure tolerance (using modified gloucester comfort scale), cecal insertion and withdrawal times, polyp detection rate, and patients' experiences related to colonoscopy were recorded. Likert scales were collected as well just after the colonoscopy procedure, indicating satisfaction and willingness to repeat the process.


Recruitment information / eligibility

Status Completed
Enrollment 92
Est. completion date November 30, 2023
Est. primary completion date November 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - Between 18-70 years old who had scheduled colonoscopy appointments Exclusion Criteria: - Anxiety and panic disorders - Urgent endoscopic intervention - Advanced dementia - Hearing problems - Anatomical or inflammatory disorders in the external ear canals

Study Design


Intervention

Other:
binaural music
In the binaural music group, an MP3 player and in-ear stereo headphones were provided. Music therapy was applied during the procedure.

Locations

Country Name City State
Turkey Abdurrahman Yurtaslan Oncology and Training Research Hospital Ankara

Sponsors (1)

Lead Sponsor Collaborator
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Isik BK, Esen A, Buyukerkmen B, Kilinc A, Menziletoglu D. Effectiveness of binaural beats in reducing preoperative dental anxiety. Br J Oral Maxillofac Surg. 2017 Jul;55(6):571-574. doi: 10.1016/j.bjoms.2017.02.014. Epub 2017 Mar 18. — View Citation

Tani A, Tartarisco G, Vagheggini G, Vaccaro C, Campana S, Tomaiuolo F. Binaural beats reduce feeling of pain and discomfort during colonoscopy procedure in not-sedated patients: A randomized control trial. Complement Ther Clin Pract. 2022 Aug;48:101605. d — View Citation

Wang MC, Zhang LY, Zhang YL, Zhang YW, Xu XD, Zhang YC. Effect of music in endoscopy procedures: systematic review and meta-analysis of randomized controlled trials. Pain Med. 2014 Oct;15(10):1786-94. doi: 10.1111/pme.12514. Epub 2014 Aug 19. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary VAS-anxiety The VAS scale, developed by Price et al. (1983), has been employed in recent years to measure patients' subjective experiences of pain and anxiety.This scale utilizes a 10-cm horizontal or vertical line, with the two endpoints representing the minimum and maximum scores for pain and anxiety(0: no pain/no anxiety, 10: the most severe pain/extremely anxious). The colonoscopy nurse recorded patients' pain and anxiety scores by manually marking a 10-cm line. This indicator is a reliable measure for assessing pain and anxiety immediately before being taken into the procedure room and 5 minutes after the procedure
Primary VAS-pain The VAS scale, developed by Price et al. (1983), has been employed in recent years to measure patients' subjective experiences of pain and anxiety.This scale utilizes a 10-cm horizontal or vertical line, with the two endpoints representing the minimum and maximum scores for pain and anxiety(0: no pain/no anxiety, 10: the most severe pain/extremely anxious). The colonoscopy nurse recorded patients' pain and anxiety scores by manually marking a 10-cm line. This indicator is a reliable measure for assessing pain and anxiety 5 minutes after the procedure
Primary The Modified Gloucester Comfort Scale The endoscopy nurse recorded and analyzed data related to patient comfort, encompassing compliance and tolerance during the procedure, using the Modified Gloucester Comfort Scale.Discomfort, characterized by severe belching, retching, coughing, and non-compliance, was assessed on a scale where the absence of discomfort received a score of 1 point, while extreme discomfort during the procedure was assigned 5 points. During the procedure
Secondary Patient satisfaction After the procedure, the patients were asked a series of questions for procedure evaluation (worse than expected, as expected, better than expected) and their willingness to have endoscopy again for their health (no, yes). The binaural music group was asked a three-item question with "yes-not sure-no" responses, inquiring whether the music increased relaxation and if they would like to listen to the same music again during a repeat procedure. 5 minutes after the procedure
Secondary Heart rate The comparison of heart rate in the music and control groups Within 20 minutes pre-procedure and 5 minutes after the procedure
Secondary Blood pressure The comparison of systolic and diastolic blood pressure in the music and control groups Within 20 minutes pre-procedure and 5 minutes after the procedure
Secondary cecal insertion time(minutes) Insertion time, as defined, refers to the duration between the initiation of the colonoscopy procedure and the moment when the endoscope reaches the cecum, with identification of the appendiceal orifice. during the procedure
Secondary withdrawal time (minutes) Withdrawal time, as defined, refers to the period between the commencement of withdrawing the colonoscope from the cecum and the complete removal of the colonoscope from the patient. during the procedure
Secondary polyp detection rate It will be assessed by recording the encountered polyps during colonoscopy. during the procedure
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